In a press statement released on Jan. 6, 2023, the European Commission reported the adoption of a proposal to allow more time to certify medical devices to mitigate the risk of shortages. The proposal introduces a longer transition period to adapt to new rules, as foreseen under the Medical Devices Regulation (MDR).

According to the commission, the new deadlines depend on the medical devices’ risk class and will ensure continued access to medical devices for patients. It will also allow medical devices placed on the market in accordance with the current legal framework and that are still available to remain on the market (i.e., no “sell-off” date).

“Our rules on medical devices will always prioritize patient safety and support for innovation,” says Stella Kyriakides, EU Commissioner for Health and Food Safety. “A combination of factors has left healthcare systems across the EU facing a risk of shortages of life-saving medical devices for patients. Today, we propose a revised regulatory timeline to provide certainty to industry in order to continue producing essential medical devices, reducing any short-term risk of shortages, and safeguarding access for patients most in need.”

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